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Home»Services»CMC Support»Cell Bank Testing»E coli Cell Bank Testing

E. coli Cell Bank Characterization Services

E. coli cell bank release testing is essential for biopharmaceutical production of plasmids and therapeutic proteins. Regulatory agencies require thorough characterization of the identity, purity, and genetic stability of the E. coli cell banks used in GMP manufacturing. This ensures the cell bank is contaminant-free, genetically stable, and possesses the necessary characteristics for reliable and safe bioprocesses.

E. coli Pre-bank Testing

Critical Quality Attributes

Assay

Description

Lytic Phage Detection

Microbiological assay to test for presence of lytic phage in cell bank

Purity

Lysogenic Phage Detection

Microbiological assay to test for presence of lysogenic phage in cell bank

Phage ID Confirmation

Confirmation of phage identity by NGS

Identity

Plasmid Sequencing

Confirmation of full or partial sequence of the plasmid by Sanger sequencing or NGS

E. coli Cell Bank Testing (CGMP)

Critical Quality Attributes

Assay

Description

Identity

Species ID

Confirmation of bacterial species using bioMerieux API20E test

Plasmid Sequence Confirmation

Confirmation of full or partial sequence of the plasmid by Sanger sequencing or NGS

Strain ID

Various biochemical tests to confirm the strain’s genotype based on phenotypic characteristics

Identity

Species ID

Confirmation of bacterial species using bioMerieux API20E test

Gram Staining

Confirmation of Gram Stain phenotype of bacterial cell bank

Colony Morphology Testing

Confirm morphology of colonies after expansion of cells on agar plates

Purity

Lytic Phage Detection

Microbiological assay to test for presence of lytic phage in cell bank

Purity Testing

Test for aerobic and anaerobic bacteria and aerobic fungi in cell bank

Purity

Lytic Phage Detection

Microbiological assay to test for presence of lytic phage in cell bank

Lysogenic Phage Detection

Microbiological assay to test for presence of lysogenic phage in cell bank

Stability

Plasmid Gene of Interest Sequence Confirmation

Confirmation of full or partial sequence of the plasmid in MCB, WCB, and EOPC by Sanger sequencing

Marker Retention

Determine percentage of cells capable of maintaining selectable marker/plasmid

Plasmid Copy Number

Quantify copies of plasmid per cell in MCB, WCB, and EOPC by QPCR or ddPCR

Stability

Plasmid Gene of Interest Sequence Confirmation

Confirmation of full or partial sequence of the plasmid in MCB, WCB, and EOPC by Sanger sequencing

Viability Testing

Determine percentage of viable cells in cell bank (cfu/ml)

mRNA Sequencing

Sequencing of the target gene of protein expression in MCB, WCB, and EOPC by Sanger sequencing

Other E. coli Cell Bank Testing

Critical Quality Attributes

Assay

Description

Other

16S rRNA Sequencing

Identification of Bacterial species by 16S/ITS Sequencing by Sanger

Antibiotic Sensitivity Testing

Confirmation of antibiotic resistance in E. coli cell bank

Other

16S rRNA Sequencing

Identification of Bacterial or Fungal species by 16S/ITS Sequencing by Sanger

E. coli Genome Confirmation

Confirmation of full or partial E coli genome by NGS

Phage ID Confirmation

Testing for line clearance of residual plasmid using TaqMan assays targeting Kanamycin or other plasmid sequences in between plasmid batch production by QPCR

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